Radiosensitivity of HPV-related Tumors: Towards a Genomic... | NCT06321627

Studies
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

NCT06321627

Sponsor

European Institute of Oncology

Status

Unknown status

Last Update Posted

Mar 20, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

HPV-Related Carcinoma

Interventions

Radiation therapy as curative treatment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

Detailed Description

The present study (ICARUS - genomIC RAdiosensitivity viRUS) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with HPV-related tumors of the oropharynx, cervix, and anus.

The aim is to:

investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
compare the Radiation Sensitivity Index (RSI) values of HPV-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with HPV-related tumors		Patients with HPV-related tumors of the oropharynx, cervix, and anus	Radiation: Radiation therapy as curative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation therapy as curative treatment	Radiation	Radiation therapy as curative treatment (exclusive, post-operative, with or without chemotherapy) for HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease free survival	Number of patients with a recurrence (local or distant) after 5 years	5 years

Secondary Outcomes

Measure	Description	Time Frame
Genetic patterns of radiosensitivity	The biopsy samples from patients included in the database will be collected for the validation analyses of RadioSensitivity Index (RSI). The calculation of RSI will be performed using a panel of 10 genes extracted from the tumor biopsy.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (>18 years old)
Diagnosis of HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus
Curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy)
Availability of pre-radiation therapy biopsy sample
No diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years
Possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in RT.dose format)
Ability to obtain written informed consent for the use of data anonymously for research purposes

Exclusion Criteria:

Patients undergoing surgical treatment
Patients with local and/or locoregional recurrence
Patients with synchronous distant metastases at diagnosis
Patients previously treated with oncologic therapies for tumors of the same anatomical site

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with HPV-positive tumors of the oropharynx, uterine cervix, and anus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Alterio, MD	Contact	+390257489629		daniela.alterio@ieo.it

Overall Officials

Name	Affiliation	Role
Daniela Alterio	European Institute of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
European Institute of Oncology	Recruiting	Milan			Italy